Clark 2010.

Methods	Included as outcome evaluation Study design: clustered parallel‐group design with schools selected as the unit of randomisation Setting: study was conducted at 19 middle schools in Detroit, Michigan, USA. Seven schools were randomised to one of the treatment arms, 6 schools to another treatment arm, and 6 schools to a control arm Period: this was a 5‐year study with a 2‐year enrolment period starting in 2003
Participants	Eligible sample frame: through a case detection survey, 1292 students were identified as probably having asthma (and eligible for the intervention) Randomised: students randomised at the school level ‐ 468 pupils in one treatment arm, 416 in a second treatment arm, and 408 in a control arm Completed (intervention): data from 921 pupils were collected at 12‐month follow‐up; disaggregated numbers by trial arm were not reported Inclusion criteria: students were eligible for participation in the study if they met the "definition of probable asthma as well as levels of severity based on NAEPP guidelines" Exclusion criteria: no further criteria reported Baseline characteristics Age of children: mean age, 11.6 years across all 3 trial arms Ethnicity: 93% of children involved in the study were African American; this varied between 90% and 98% across trial arms Socio‐economic status: a large proportion of children were from low‐income households ‐ 48% of all children (44% to 50% across different arms) were from households with annual income under $15,000 per annum Gender: 48% of children were female (ranging from 46% to 50% across different trial arms) Asthma status: indicators of asthma severity at baseline included 58% of children (caregivers) reporting obtaining prescriptions for asthma medications in the past year and 52% reporting persistent night‐time asthma
Interventions	Intervention: trial included 2 treatment arms and 1 control arm. Both treatment arms tested the effectiveness of different forms of Open Airways for Schools (OAS): Treatment arm 1: adapted form of OAS delivered as a 6‐ to 7‐lesson curriculum including interactive problem‐solving activities appropriate for groups of pre‐teens. Topics included (I) basic information and feelings about asthma; (ii) facts about asthma medicines and their use (emphasising partnership with the physician); (iii) how to make good decisions about activities; (iv) how to manage an asthma attack at home or school, deciding when to go to the doctor, and making the doctor visit more effective; (v) how to keep yourself healthy, including smoking avoidance; and (vi) personal characteristics, actions, and environmental factors that lead to successful asthma control. Groups of pre‐teens met during school hours for approximately 1½ hours each week for 6 weeks. Take‐home assignments and handout materials for parents were provided at each session Treatment arm 2: included the adapted OAS above and a peer education component. Peer leaders were sought from the general population of eighth grade students and were trained by project staff to provide 3 asthma awareness lessons to seventh grade students. Two to three peer leaders were trained as a team. Peer leaders developed skits and game shows as part of training to impart an important message about asthma. Teams of peer leaders taught the 3 asthma awareness lessons to seventh grade students. Participants discussed a video, played games demonstrating and testing asthma knowledge, and discussed barriers to self‐management. Finally, younger students voted on key messages to communicate to sixth grade schoolmates. In step 3, with help from peer leaders, project staff, and a teacher, seventh grade students translated asthma messages into skits, songs, and dramas, and performed these for an assembly of sixth grade students. All 3 steps focused on enabling students to understand and support their classmates with asthma Control: treatment not described (usual care) Intensity: students in treatment group 1 received 6 lessons; students in treatment group 2 received the same 6 lessons and additional input that differed depending on school grade Instructor: OAS sessions were led by graduate students and community leaders who were trained in programme methods and approach; in treatment arm 2, some components may have been delivered directly by peers Theoretical framework: not explicitly discussed Parental engagement: not reported Child satisfaction: not reported Timing of intervention in school day: described as during school day (not after school), but exact timing not reported
Outcomes	Data on daytime and night‐time symptoms were extracted
Notes	Health‐related quality of life and experience of daytime and night‐time symptoms were collected, but data needed for extraction and inclusion in meta‐analysis were not presented Considered as a process evaluation: did not include implementation research questions nor in‐depth process or contextual information (did not meet the criteria for a process evaluation) Funding source: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Schools were stratified by geographical location and disease prevalence to ensure homogeneity across groups. Within each of the resulting 4 strata, schools were randomised via a table of random numbers
Allocation concealment (selection bias)	High risk	Potential for concealment to be breached through open random numbers table
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unclear which measures were taken to ensure blinding of participants
Blinding of outcome assessment (detection bias) All outcomes	High risk	Likely any blinding of interviewers would have been breached through data collection methods: data were collected from school records and through face‐to‐face interviews with students at each school
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Missing data and attrition did occur ‐ but impacts were said to have been attenuated through multiple imputations
Selective reporting (reporting bias)	High risk	Risk of selective reporting was high, as outcomes were not reported in full and we were not able to extract several outcomes of interest
Other bias	Unclear risk	Missingness ‐ unclear risk ‐ missingness was present, but multiple imputations were implemented and impact is unknown Baseline imbalance ‐ high risk ‐ at baseline, despite randomisation, one intervention arm had lower grades than controls. This may impact responsiveness to the intervention Risk of contamination ‐ low ‐ schools were the unit of analysis
Transparent and clearly stated aims	Unclear risk	N/A
Explicit theories underpinning and/or literature review	Unclear risk	N/A
Transparent and clearly stated methods and tools	Unclear risk	N/A
Selective reporting	Unclear risk	N/A
Harmful effects	Unclear risk	N/A
Population and sample described well	Unclear risk	N/A
Continuous evaluation	Unclear risk	N/A
Evaluation participation equity and sampling	Unclear risk	N/A
Design and methods overall approach	Unclear risk	N/A
Tools and methods of data collection reliable/credible	Unclear risk	N/A
Tools and methods of data analysis reliable/credible	Unclear risk	N/A
Performance bias/neutrality/credibility/conformability	Unclear risk	N/A
Reliability of findings and recommendations	Unclear risk	N/A
Transferability of findings	Unclear risk	N/A
Overall risk of bias of process evaluation	Unclear risk	N/A